High Dose IV Iron Plus ESA in Chemotherapy-induced Anemia

Anemia Clinical Trial

Official title:

Prospective, Multicenter, Randomized Phase 3 Trial of High Dose IV Iron in Combination of Erythrocytosis Stimulating Agents in Chemotherapy Induced Anemia With Functional Iron Deficiency

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05768997
• Other study ID #: HIGHEST-CIA
• Status: Recruiting
• Phase: Phase 3
• Start date: March 1, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2023
• Source: Hallym University Medical Center
• Contact: Dae Young Zang, Ph.D.
• Phone: +82-31-380-3704
• Email: fhdzang[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a multicenter, prospective, randomized phase 3 clinical study comparing the efficacy and safety of the combination treatment of ESA and high-dose IV iron (darbepoietin alfa + ferric derisomaltose/iron isomaltoside) with ESA monotherapy (darbepoietin alfa alone) in CIA patients with functional iron deficiency.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 312
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Patient who has signed a written consent

• Age = 19 ? Histologically diagnosed advanced/metastatic solid cancer

• Patients who have received myelosuppressive chemotherapy for palliative purposes within 1 month of participating in the study and plan to proceed with chemotherapy while participating in this study

• Anemia with functional iron deficiency

1. Hemoglobin <10g/dL

2. functional iron deficiency: transferrin saturation <50% AND serum ferritin 30-800ng/mL ? ECOG performance status 0-2 ? life expectancy = 24weeks

Exclusion Criteria:

• Absolute iron deficiency (serum ferritin <30 ng/mL AND transferrin saturation <20%) or no iron deficiency (serum ferritin =800 ng/mL OR transferrin saturation =50%)

• If there is another cause of anemia other than chemotherapy-induced anemia (eg, vitamin B12 or folic acid deficiency, hemolytic anemia, myelodysplastic syndrome, etc.)

• Ongoing bleeding at the time of study registration

• Patients who require rapid blood transfusion at the time of study registration (eg, rapidly progressing anemia)

• Presence of bone marrow tumor invasion

• Receiving erythropoiesis stimulating agents within 3 weeks of study registration or have a history of oral or intravenous iron administration or blood transfusion within 2 weeks of study registration

• History of venous thromboembolism within 6 months or taking anticoagulants at the time of study registration

• Past or family history of hemochromatosis ? History of hypersensitivity to iron treatment or erythropoiesis stimulating agents ? Uncontrolled acute or chronic infection ? Renal dysfunction (serum creatinine =2.0 mg/dL, or glomerular filtration rate <30 mL/min/1.73 m2) or liver dysfuction (AST or ALT 3 times or more the upper limit of normal) ? Pregnant or lactating women

Related Conditions & MeSH terms

• Anemia

Intervention

Drug:
• Ferric Derisomaltose Injection
Ferric derisomaltose/iron isomaltoside (as iron) (0 weeks): 20mg/kg, diluted in 250ml of 0.9% physiological saline and injected intravenously over 30-60 minutes
• Darbepoetin Alfa Injection
Darbepoietin alfa (0 weeks, 3 weeks, 6 weeks, 9 weeks): 6.75?/kg, subcutaneous or intravenous administration

Locations

Country	Name	City	State
Korea, Republic of	Hallym University Medical Center	Anyang-si

Sponsors (1)

Lead Sponsor	Collaborator
Hallym University Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Hb change	Mean change in Hb concentration from baseline to 12 weeks	from baseline to 12 weeks
Secondary	Hemoglobin response	defined as an increase in Hb level of 2.0g/dL= from baseline value during 12-week study period	during 12-week study period
Secondary	Time to hemoglobin response		during 12-week study period
Secondary	Proportion of patients requiring RBC transfusion during 12-week study period		during 12-week study period
Secondary	Quality of life assessment by Functional Assessment of Cancer Therapy-Anemia (FACT-An)/health-related quality of life instrument with 8 items (HINT-8)/EQ-5D-5L		during 12-week study period
Secondary	Safety analysis	Adverse events including AE of special interst (Anaphylaxis, Infusion reaction, Thromboembolic event)	during 12-week study period